Supplemental Evidence and Data Request on Environmental, Clinical and Economic Outcomes of Hospital Resources To Prevent Hospital-Acquired Infections, 65911-65912 [2024-17935]
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Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Notices
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[FR Doc. 2024–18005 Filed 8–12–24; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Environmental, Clinical
and Economic Outcomes of Hospital
Resources To Prevent HospitalAcquired Infections
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submission.
AGENCY:
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Environmental, Clinical and Economic
Outcomes of Hospital Resources to
Prevent Hospital-Acquired Infections,
which is currently being conducted by
the AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before September 12, 2024.
ADDRESSES:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:55 Aug 12, 2024
Jkt 262001
Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane,
Mail Stop 06E77D, Rockville, MD
20857.
FOR FURTHER INFORMATION CONTACT:
Kelly Carper, Telephone: 301–427–1656
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Environmental, Clinical
and Economic Outcomes of Hospital
Resources to Prevent Hospital-Acquired
Infections. AHRQ is conducting this
review pursuant to section 902 of the
Public Health Service Act, 42 U.S.C.
299a.
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Environmental, Clinical
and Economic Outcomes of Hospital
Resources to Prevent Hospital-Acquired
Infections. The entire research protocol
is available online at: https://effective
healthcare.ahrq.gov/products/preventhai/protocol.
This is to notify the public that the
EPC Program would find the following
information on Environmental, Clinical
and Economic Outcomes of Hospital
Resources to Prevent Hospital-Acquired
Infections helpful:
D A list of completed studies that
your organization has sponsored for this
topic. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements, if relevant: study number,
PO 00000
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65911
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, primary and secondary
outcomes, baseline characteristics,
number of patients screened/eligible/
enrolled/lost to follow-up/withdrawn/
analyzed, effectiveness/efficacy, and
safety results.
D A list of ongoing studies that your
organization has sponsored for this
topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including, if relevant, a study
number, the study period, design,
methodology, indication and diagnosis,
proper use instructions, inclusion and
exclusion criteria, and primary and
secondary outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this topic and an index
outlining the relevant information in
each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on topics not included in
the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://effectivehealthcare.ahrq.gov/
email-updates.
The review will answer the following
questions. This information is provided
as background. AHRQ is not requesting
that the public provide answers to these
questions.
Guiding Questions (GQ)
GQ 1. What healthcare research
examines the health, economic, and
environmental outcomes of reprocessed
reusable devices and items or
reprocessed single-use devices and
items compared with non-reprocessed
single-use devices and items in hospital
settings?
GQ 2. What are key evidence gaps and
opportunities for future research?
E:\FR\FM\13AUN1.SGM
13AUN1
65912
Federal Register / Vol. 89, No. 156 / Tuesday, August 13, 2024 / Notices
PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, AND SETTING) INCLUSION AND EXCLUSION
CRITERIA
Category
Inclusion criteria
Population .............
Primary: Individuals receiving acute medical care .........................................................
Secondary: Healthcare workers using or caring for devices used in patient care ........
Primary interest: Devices/items that are intended to prevent infection or are used for
general bedside care, including but not limited to PPE, drapes, linens,
laryngoscopes, blood pressure cuffs, pulse oximeters.
Secondary interest: Other devices/items used during hospital care, including but not
limited to: surgical devices, other scopes.
Regulatory status: All devices/items must be either ......................................................
Interventions .........
Comparators .........
Outcomes .............
Timing ...................
Setting ..................
Publication type ....
Exclusion criteria
• FDA approved as reusable, and reprocessed per specifications.
OR
• Designated as single-use, FDA authorized for reprocessing, and reprocessed
per specifications.
Devices/items that are approved as single-use and are discarded after one use ........
Health outcomes (Patient-level or aggregated patient data) .........................................
Outcomes include but are not limited to: HAI, SSI, or pathogen transmission (including MDRO; Sepsis; ICU stay related to HAI; Length of stay; Mortality; Adverse effects; Healthcare worker infection or injury.
Economic outcomes (Hospital/health system perspective) ............................................
Outcomes include but are not limited to: Procurement cost; Cost per procedure/use;
Costs for: reprocessing, transportation, storage, functionality testing, maintenance,
repair, disposal, replacement; Supply chain implications.
Environmental outcomes
a. Environmental impact
(Global, national, or regional perspective).
Outcomes include but are not limited to: Greenhouse gas emissions; Air pollution;
Water use; Water contamination; Energy use; Chemical use and toxicity; Recycling
volume; Landfill use; Carcinogenic exposure; Climate change; Raw material extraction and processing.
b. Environmental health
(Population health perspective).
Outcomes include but are not limited to: Respiratory illness; Cardiovascular disease;
Cancer risk; Infectious disease outbreaks.
Any ..................................................................................................................................
Acute care hospitals in countries rated ‘‘very high’’ on the 2021 Human Development
Index (as defined by the United Nations Development Programme) *.
English language ............................................................................................................
For primary interest interventions (devices/items used to prevent infections or for
general bedside care): SRs, randomized controlled trials, nonrandomized controlled studies.
For secondary interest interventions (other devices/items used for hospital care):
SRs.
Individuals receiving ambulatory care.
Devices/items with minimal or no pathogen transmission
risk.
Devices/items primarily used in an ambulatory or nonacute-care setting.
Devices/items that have been reprocessed under emergency use authorization only.
Implantable devices other than catheters.
Single-use devices/items for which no reusable or authorized reprocessed alternatives are available in the
US.
Quality of reprocessing.
Usability by healthcare workers or patients.
Device/item preferences of healthcare workers or patients.
Device/item availability.
Bacterial colonization of device/item.
NA.
Non-hospital settings.
Other countries.
Non-English-language, abstracts, case reports, noncomparative studies, narrative reviews, commentaries,
guidelines.
FDA: Food and Drug Administration; HAI: Healthcare-associated infection; ICU: Intensive care unit; MDRO: Multi-drug resistant organism; NA: Not applicable; PPE:
Personal protective equipment; SR: Systematic review; SSI: Surgical site infection; US: United States.
* Human development index. United Nations Development Programme. Accessed April 16, 2024. https://hdr.undp.org/data-center/human-development-index#/
indicies/HDI.
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024–17935 Filed 8–12–24; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
lotter on DSK11XQN23PROD with NOTICES1
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
Notice.
This notice announces the
intention of the Agency for Healthcare
SUMMARY:
VerDate Sep<11>2014
17:55 Aug 12, 2024
Jkt 262001
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at
REPORTSCLEARANCEOFFICER@
ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
Comments on this notice must be
received by October 15, 2024.
Proposed Project
Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by
email at
REPORTSCLEARANCEOFFICER@
ahrq.hhs.gov.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
Surveys on Patient Safety Culture®
(SOPS®) Ambulatory Surgery Center
(ASC) Survey Database
In 1999, the Institute of Medicine
called for healthcare organizations to
develop a ‘‘culture of safety’’ such that
their workforce and processes focus on
improving the reliability and safety of
care for patients (IOM, 1999; To Err is
Human: Building a Safer Health
ADDRESSES:
AGENCY:
ACTION:
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the extension
without change of the currently
approved information collection
‘‘Surveys on Patient Safety Culture
(SOPS) Ambulatory Surgery Center
(ASC) Survey Database, (OMB No.
0935–0242).’’
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]]>Agencies
[Federal Register Volume 89, Number 156 (Tuesday, August 13, 2024)]
[Notices]
[Pages 65911-65912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17935]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Environmental, Clinical
and Economic Outcomes of Hospital Resources To Prevent Hospital-
Acquired Infections
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submission.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Environmental,
Clinical and Economic Outcomes of Hospital Resources to Prevent
Hospital-Acquired Infections, which is currently being conducted by the
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to
published and unpublished pertinent scientific information will improve
the quality of this review.
DATES: Submission Deadline on or before September 12, 2024.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement,
Agency for Healthcare Research and Quality, ATTN: EPC SEADs
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
Shipping Address (FedEx, UPS, etc.): Center for Evidence and
Practice Improvement, Agency for Healthcare Research and Quality, ATTN:
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: Kelly Carper, Telephone: 301-427-1656
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Environmental,
Clinical and Economic Outcomes of Hospital Resources to Prevent
Hospital-Acquired Infections. AHRQ is conducting this review pursuant
to section 902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Environmental, Clinical and Economic Outcomes of
Hospital Resources to Prevent Hospital-Acquired Infections. The entire
research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/prevent-hai/protocol.
This is to notify the public that the EPC Program would find the
following information on Environmental, Clinical and Economic Outcomes
of Hospital Resources to Prevent Hospital-Acquired Infections helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this topic. In the list, please indicate whether results
are available on ClinicalTrials.gov along with the ClinicalTrials.gov
trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements, if
relevant: study number, study period, design, methodology, indication
and diagnosis, proper use instructions, inclusion and exclusion
criteria, primary and secondary outcomes, baseline characteristics,
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
[ssquf] A list of ongoing studies that your organization has
sponsored for this topic. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including, if relevant, a study number, the
study period, design, methodology, indication and diagnosis, proper use
instructions, inclusion and exclusion criteria, and primary and
secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this topic and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on topics not included
in the review cannot be used by the EPC Program. This is a voluntary
request for information, and all costs for complying with this request
must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://effectivehealthcare.ahrq.gov/email-updates.
The review will answer the following questions. This information is
provided as background. AHRQ is not requesting that the public provide
answers to these questions.
Guiding Questions (GQ)
GQ 1. What healthcare research examines the health, economic, and
environmental outcomes of reprocessed reusable devices and items or
reprocessed single-use devices and items compared with non-reprocessed
single-use devices and items in hospital settings?
GQ 2. What are key evidence gaps and opportunities for future
research?
[[Page 65912]]
PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, and
Setting) Inclusion and Exclusion Criteria
------------------------------------------------------------------------
Category Inclusion criteria Exclusion criteria
------------------------------------------------------------------------
Population................ Primary: Individuals Individuals receiving
receiving acute ambulatory care.
medical care.
Secondary: Healthcare
workers using or
caring for devices
used in patient care.
Interventions............. Primary interest: Devices/items with
Devices/items that minimal or no
are intended to pathogen
prevent infection or transmission risk.
are used for general Devices/items
bedside care, primarily used in an
including but not ambulatory or non-
limited to PPE, acute-care setting.
drapes, linens, Devices/items that
laryngoscopes, blood have been
pressure cuffs, reprocessed under
pulse oximeters. emergency use
Secondary interest: authorization only.
Other devices/items Implantable devices
used during hospital other than
care, including but catheters.
not limited to:
surgical devices,
other scopes.
Regulatory status:
All devices/items
must be either.
FDA
approved as
reusable, and
reprocessed per
specifications.
OR
Designated as
single-use, FDA
authorized for
reprocessing, and
reprocessed per
specifications.
Comparators............... Devices/items that Single-use devices/
are approved as items for which no
single-use and are reusable or
discarded after one authorized
use. reprocessed
alternatives are
available in the US.
Outcomes.................. Health outcomes Quality of
(Patient-level or reprocessing.
aggregated patient Usability by
data). healthcare workers
Outcomes include but or patients.
are not limited to: Device/item
HAI, SSI, or preferences of
pathogen healthcare workers
transmission or patients.
(including MDRO; Device/item
Sepsis; ICU stay availability.
related to HAI; Bacterial
Length of stay; colonization of
Mortality; Adverse device/item.
effects; Healthcare
worker infection or
injury.
Economic outcomes
(Hospital/health
system perspective).
Outcomes include but
are not limited to:
Procurement cost;
Cost per procedure/
use; Costs for:
reprocessing,
transportation,
storage,
functionality
testing,
maintenance, repair,
disposal,
replacement; Supply
chain implications.
Environmental
outcomes
a. Environmental
impact
(Global, national, or
regional
perspective).
Outcomes include but
are not limited to:
Greenhouse gas
emissions; Air
pollution; Water
use; Water
contamination;
Energy use; Chemical
use and toxicity;
Recycling volume;
Landfill use;
Carcinogenic
exposure; Climate
change; Raw material
extraction and
processing.
b. Environmental
health
(Population health
perspective).
Outcomes include but
are not limited to:
Respiratory illness;
Cardiovascular
disease; Cancer
risk; Infectious
disease outbreaks.
Timing.................... Any.................. NA.
Setting................... Acute care hospitals Non-hospital
in countries rated settings.
``very high'' on the Other countries.
2021 Human
Development Index
(as defined by the
United Nations
Development
Programme) *.
Publication type.......... English language..... Non-English-language,
For primary interest abstracts, case
interventions reports, non-
(devices/items used comparative studies,
to prevent narrative reviews,
infections or for commentaries,
general bedside guidelines.
care): SRs,
randomized
controlled trials,
nonrandomized
controlled studies.
For secondary
interest
interventions (other
devices/items used
for hospital care):
SRs.
------------------------------------------------------------------------
FDA: Food and Drug Administration; HAI: Healthcare-associated infection;
ICU: Intensive care unit; MDRO: Multi-drug resistant organism; NA: Not
applicable; PPE: Personal protective equipment; SR: Systematic review;
SSI: Surgical site infection; US: United States.
* Human development index. United Nations Development Programme.
Accessed April 16, 2024. https://hdr.undp.org/data-center/human-development-index#/indicies/HDI.
Mamatha Pancholi,
Deputy Director.
[FR Doc. 2024-17935 Filed 8-12-24; 8:45 am]
BILLING CODE 4160-90-P
